The «PSUR/ PBRER for human medicines HMV4» form has been updated. New guidance on submitting periodic safety update reports (PSURs) for drugs was released by China's State Food and Drug Administration (SFDA) on 6 September.  The guidance conforms to the harmonized PSUR standards developed by the International Conference on Harmonization [ICH E2C (R1)]. The European Medicines Agency maintains a list of EU reference dates and frequency of submission of PSURs (EURD list) for active substances contained in medicines in the EU and is updated on an ongoing basis.Marketing Authorisation Holders (MAHs) are required to submit PSURs according to the data lock points published in the EURD list. The PSUR work sharing and synchronisation project was initiated in 2002 under the auspices of the HMA and the European Risk Management Strategy Facilitation Group (ERMS FG). The PSUR Repository provides an important simplification for marketing authorisation holders allowing them to send all PSURs and related submissions to a single recipient. The TGA applies the requirement to submit PSUR as a condition of registration PSURs are not required for all registered medicines. A risk-based approach is used to determine the requirement, frequency and duration of PSUR submission PSUR submission is . Definition • Periodic safety update reports (PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the post- authorisation phase. Template - PSUR Assessment Report; Template - Lead Member State PSUR Follow-Up assessment report ; The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. Unless there is a specific condition in the authorisation, or it is indicated otherwise in the EURD list, routine PSUR reporting is not required for medicinal products authorised under the following articles of Directive 2001/83/EC:All PSURs should be submitted to the PSUR repository using the eSubmission Gateway/Web Client: Information on the repository, guidance on how to register and multimedia tutorials for MAHs on how to submit a PSUR, as well as on the correct structured electronic formats, can be found on EMA’s PSUR repository web pages here: Further information for MAHs on changes to submission of PSURs for human medicines is available here: Users of the repository should direct any questions on use of the EMA PSUR repository and/or the eSubmission Gateway/Web Client to the EMA Service Desk portal: For further information on submission dates, PSUSA procedure number and requirements for submission of products referred to in articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended please refer to the Detailed guidance on procedural aspects of the EU single assessment is available on the EMA website: Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland, D02 XP77 PSUR Work Sharing and Synchronisation Project. MU103_10_002e_FO Form PSUR/PBRER … This release provides minor changes to the MAH and NCA user interfaces, new features for EMA users and number of new notifications for all users. It also facilitates the assessment by ensuring that NCAs, EMA and its scientific committees have timely and secure access to all relevant documents. Marketing Authorisation Holders (MAHs) are required to submit PSURs according to the data lock points published in the EURD list. By using this website, you consent to the use of cookies in accordance with the HPRA Cookie Policy. CMDh SOP on the processing of PSUR single assessment for nationally authorised products (May 2016) [Track version] More information regarding the PSUR single assessment is published on the EU webportal (currently EMA website) The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. It also facilitates the assessment by ensuring that NCAs, EMA and its scientific committees have timely and secure access to all relevant documents. PSUR Repository user registration form for NCA usersEudraVigilance system downtime – impact on PSUR Repository and the eAFAutomated two-way exchange of documents held in the PSUR Repository between NCA systems and the PSUR Repository to reduce administrative burden for NCAs .Please note that procedural questions on non-EU single assessment procedures conducted only in one Member State must be addressed to the relevant National Competent Authority. (GVP ModuleVII) • Information on the latest approved ICH E2E / RMP documentation is now requested under «Supplementary documents submitted» and redundant administrative information has been removed from the form. A Periodic Safety Update Report is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points post-authorisation.